METACRYL
Resin, Denture, Relining, Repairing, Rebasing
GREAT LAKES ORTHODONTICS, LTD.
The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Metacryl.
Pre-market Notification Details
| Device ID | K040881 |
| 510k Number | K040881 |
| Device Name: | METACRYL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Contact | Mark Lauren |
| Correspondent | Mark Lauren GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-05 |
| Decision Date | 2004-05-25 |
| Summary: | summary |
Trademark Results [METACRYL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 METACRYL 85326216 4119684 Live/Registered |
ChemSpec USA, LLC 2011-05-20 |
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